Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
Summary:
The Senior Director Data Management (EMEA & NA), (SrDDM) leads and oversees operational activities of the Allucent Data Management (DM) department to one or more global regions.
The SrDDM has (global) people management responsibilities and controls and monitors Data Management activities, providing leadership and expertise in relevant technical areas and cross-functional initiatives, including the development of departmental processes, tools and training of staff.
The SrDDM is a member of the Data Management staff.
Key Responsibilities:
Clinical Data Management
Contribute to the identification, development and implementation of the business strategy for the Data Management department
Contribute to development of annual revenues, sales, profit and operational targets for the Data Management department
Evaluate and contribute to the development of the Data Management department strategy and tactics planning
Develop, agree and approve operating procedures / business processes
Manage direct reporting staff and oversee and manage (global) teams
Review and verify the needs of the department for tools, processes, resourcing, and personnel and take action upon these needs
Review and verify the availability of required capable resources for the area and take action upon these needs
Verify the availability of required capable resources for the area
Collaborate and ensure open communication with other functional groups and departments
Report to the leaderships team
Work closely with the (Executive) (Senior) Directors and Vice President, Global Head of Data Management, Project Directors and functional heads of other departments so that global consistency, focus and development are achieved across the company
Oversee contractual and financial aspects of projects, utilization rate and profitability
Verify activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care
Ensure consistency and standardization of data management to complete project deliverables on schedule and according to quality standards and requirements of the study
Recognize and solve potential problems and evaluate effectiveness
Oversee Sponsor relationships
Assist in audits and regulatory inspections
Review and approve key DM documents and deliverables (if applicable)
Serve as project advisor to project teams regarding operational aspects of a project
Plan and report resources required including management of tasks, timelines, risk and quality
Recognize potential problems across projects, propose and develop short-term and long-term solution and improvement strategies and evaluate effectiveness
Apply expertise to identify gaps and proposes solutions to improve efficiency of data management tasks to improve overall quality of data management deliverables.
Collaborate with other Allucent departments and teams to ensure overall success of project.
Serve as project advisor/consultant to cross-functional project teams regarding technical and operational aspects of project
Apply expertise to identify gaps and proposes solutions to improve efficiency of data management tasks to improve overall quality of data management deliverables.
Management & Learning Development
- Actively manage and mentor Data Management staff in general skills, project management skills, internal company processes and for project-specific tasks
- Conduct performance evaluation, perform performance reviews and support team member personal development plans
- Proactively track data management development trends and updates, in consultation with department head and Directors, for further alignment and improvement of current processes
- Analyze and implement new development plans and actively participate in the Director team (strategy – leadership – business integration) meetings to identify and implement new area related goals and strategies
- Represent the company through active participation at professional meetings or seminars or through blogs and publications
- Participate in the interview process for new recruits
- Actively contribute to staff learning & development within the company
- Provide and coordinate Data Management training/coaching for relevant staff
- Maintain a broad overall knowledge in the field of clinical data management by reading literature, self-training, continuous professional development, attending training classes and professional meetings etc.
Requirements
- Life science, healthcare, business degree and/or combination of education and experience
- Minimum 15 years of relevant work experience as Clinical Data Manager
- Minimum 15 years of experience in drug development and/or clinical research
- Demonstrated experience in managing a team
- Demonstrated experience in managing global operations
- Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements
- In-depth knowledge of clinical trial processes, EDC systems, database programming, clinical operations, quality management, and systems applications to support operations
- Proficiency in the data management practices, including tools and processes
- Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models
- Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation
Skills:
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required
- Administrative excellence
- Attention to detail, strong technical, analytical and problem-solving skills
- Strong project management skills
- Ability to simplify complex issues into understandable concepts
- Ability to translate guidelines, rules and regulations in clear and usable recommendations
- Effective at problem solving, strategic thinking and conflict resolution
- Strong presentation and networking capabilities
- Ability to influence process, people on a global scale
- Excellent organizational, negotiating and motivational skills
- Proven strong leadership skills